18 and older, any sex, with Melanoma or Lymph Node Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Major Pathologic Response Rate (MPR)Primary· Every 6 weeks from start of study treatment, up to 52 weeks
Distribution of pathologic response in the 30 evaluable patients. Major pathologic response was defined on surgical specimens analyzed by blinded two independent dermatopathologists using immune related pathologic response criteria (irPRC). Residual viable tumor (RVT) (wherein RVT = viable tumor area/total tumor bed area) was calculated depending on the quantity of viable malignant cells on H\&E-stained slides and confirmatory SOX-10-stained representative sections in ambiguous cases; and thresholds defined as follows: complete response (pCR, 0% RVT), major response (pMR, 0%\< RVT ≤10%), parti
Group
Value
95% CI
Nivolumab and CMP-001 Combination
14
Nivolumab and CMP-001 Combination
3
Nivolumab and CMP-001 Combination
3
Nivolumab and CMP-001 Combination
10
Radiographic Response RateSecondary· Up to 31 months
Number of patients with Complete response \[CR\], partial response \[PR\], or stable disease \[SD\], per RECIST v1.1 criteria. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10mm short axis);PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to quali
Group
Value
95% CI
Nivolumab and CMP-001 Combination
14
Nivolumab and CMP-001 Combination
10
Nivolumab and CMP-001 Combination
7
Relapse-Free Survival (RFS)Secondary· Up to 31 months
Length of time from the initiation of treatment that patients survive without recurrence of disease. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progressio
Group
Value
95% CI
Nivolumab and CMP-001 Combination
NA
22.0 – NA
6-month Relapse-free SurvivalSecondary· Up to 6 months
Percentage of patients who did not experience disease relapse, 6-months post start of treatment.
Group
Value
95% CI
Nivolumab and CMP-001 Combination
81
62 – 91
12-month Relapse-free SurvivalSecondary· Up to 12 months
Percentage of patients who did not experience disease relapse, 12 months post treatment.
Group
Value
95% CI
Nivolumab and CMP-001 Combination
74
55 – 86
24-month Relapse-free SurvivalSecondary· Up to 24 months
Percentage of patients who did not experience disease relapse, 24-months post start of treatment.
Group
Value
95% CI
Nivolumab and CMP-001 Combination
62
41 – 77
Overall Survival (OS)Secondary· Up to 31 months
The length of time from the start of treatment that patients remain alive.
Group
Value
95% CI
Nivolumab and CMP-001 Combination
NA
NA – NA
6-month Overall Survival (OS)Secondary· Up to 6 months
Percentage of patients that remain alive.
Group
Value
95% CI
Nivolumab and CMP-001 Combination
100
100 – 100
12-month Overall Survival (OS)Secondary· Up to 12 months
Percentage of patients that remain alive.
Group
Value
95% CI
Nivolumab and CMP-001 Combination
87
69 – 95
24-month Overall Survival (OS)Secondary· Up to 24 months
Percentage of patients that remain alive.
Group
Value
95% CI
Nivolumab and CMP-001 Combination
83
63 – 93
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nivolumab and CMP-001 Combination
Serious: 8/34 (24%)
Deaths: 9/34
Serious adverse events (16 terms)
Reaction
System
Nivolumab and CMP-001 Comb…
Blood and lymphatic system disorders - Other, specifyhypoxemia
Blood and lymphatic system disorders
—
Restrictive cardiomyopathy
Cardiac disorders
—
General disorders and administration site conditions - Other, specifyBrain Mets
General disorders
—
General disorders and administration site conditions - Other, specifyfailure to thrive
General disorders
—
Cytokine release syndrome
Immune system disorders
—
Immune system disorders - Other, specifyMyasthenia Gravis
Immune system disorders
—
Wound infection
Infections and infestations
—
Seroma
Injury, poisoning and procedural complications
—
Cardiac troponin I increased
Investigations
—
Investigations - Other, specifyinjection site reaction
Investigations
—
Back pain
Musculoskeletal and connective tissue disorders
—
Myositis
Musculoskeletal and connective tissue disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
Skin and subcutaneous tissue disorders - Other, specifyCellulitis
Skin and subcutaneous tissue disorders
—
Surgical and medical procedures - Other, specifyCraniotomy
Surgical and medical procedures
—
Other adverse events (221 terms — click to expand)
The purpose this research study is to determine if the combination of nivolumab and CMP-001 improves the likelihood of eradicating (destroying) disease in the lymph node (pathologic response rate).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04698187 — CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma
· Phase 2
· terminated
NCT04695977 — CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma
· Phase 2, PHASE3
· terminated
NCT04633278 — CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
· Phase 2
· terminated
NCT03983668 — CMP-001 for Relapsed and Refractory Lymphoma
· Phase 1, PHASE2
· terminated
NCT03507699 — Combined Immunotherapy and Radiosurgery for Metastatic Colorectal Cancer
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Diwakar Davar
Last refreshed: 14 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03618641.